Anxiety DisordersPhase 2NCT06269146
Pramipexole to Enhance Social Connections
A Phase 2 study testing Pramipexole Pill in people with Anxiety Disorders and Anxiety, run by University of California, San Diego at 2 sites in United States.
Trial summary
This study seeks to understand if the medication pramipexole improves social connectedness and functioning in adults (ages 18-50) who experience anxiety or depression. The study plans to enroll 108 participants total across two sites (University of California San Diego and New York State Psychiatric Institute). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anxiety Disorders, Anxiety, Depression
- What is being tested?
- Pramipexole Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 May 2024to Mar 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically elevated levels of anxiety (OASIS ≥ 8) or depression or (PHQ-9 ≥ 10).
- Moderate or greater social disability assessed with clinician-rating (SDS - Social ≥ 5).
- Below the normative mean for temperamental reward sensitivity (ATQ - Approach < 35).
- Age 18-50.
- Ability to provide written informed consent.
- English proficiency.
Who cannot join
- Exclusion criteria are included to ensure that participation does not place subjects at undue risk, and to minimize confounding interpretation of our findings:
- Current, imminent risk of suicide assessed with Clinical Interview and Columbia Suicide Severity Rating Scale (C-SSRS) "yes" response to items 4, 5 (past month), 6 (past 3 months), or suicide attempt in the past year.
- History of bipolar or psychotic disorders.
- History of major neurological disorder or moderate to severe traumatic brain injury.
- History of severe or unstable medical conditions that might be compromised by participation in the study (e.g., cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease; history of seizure disorder).
- Past 6-month substance use disorder (any severity) with the exception of mild alcohol, cannabis, or tobacco use disorder, which will be permitted in the study.
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- History of impulse control problems (e.g., pathological gambling).
- First-degree relative with a diagnosis of schizophrenia-spectrum or other psychotic disorder or bipolar disorder.
- History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine; except for physician prescribed stimulants) in the past 6 months.
- History of dopaminergic agonists drug use (e.g., pramipexole, ropinirole, apomorphine, rotigotine) in the past 6 months.
- Positive urinalysis screen for psychoactive drug use (that is not physician prescribed or THC).
- Abnormal and clinically relevant blood count, liver, renal or EKG findings as determined by physician.
- Women who are pregnant, breastfeeding, or planning to become pregnant within the next 6 months. Individuals of childbearing potential must agree to use an acceptable method of contraception from at least 21 days prior to the first dose of study drug and for 3 months after the last dose of study drug for study entry.
- Concurrent empirically supported psychosocial treatments for anxiety or mood disorders (e.g., cognitive behavioral therapy).
- Use of any psychotropic medication (e.g. SSRIs, benzodiazepines) within 14 days before study entry [except for fluoxetine within 30 days]. Concurrent use is prohibited during the study
- Anticipated inability to attend regular study appointments.
- Anticipated inability to complete the study procedures as determined by study personnel.
- Clinical conditions assessed by the interviewer that necessitate more imminent clinical care. These criteria are in place so participants with these other, more severe symptoms can be referred for appropriate services (e.g. self-injurious behavior or exposure to a severe traumatic event in the past week).
- Non-correctable vision or hearing problems, as some tests require intact sensory functioning.
- No telephone or easy access to telephone.
- MRI contraindications
- CGI-S score of 6 or 7.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York State Psychiatric Institute
New York, New York, 10032
University of California, San Diego
San Diego, California, 92093
About this study
Official title: Targeting Dopamine-Mediated Social Reward Sensitivity to Remediate Social Disconnection
This study seeks to understand if the medication pramipexole improves social connectedness and functioning in adults (ages 18-50) who experience anxiety or depression. The study plans to enroll 108 participants total across two sites (University of California San Diego and New York State Psychiatric Institute). Pramipexole will be given in a 6-week randomized, double-blind, placebo-controlled trial. Social reward processing will be assessed using measures of brain function (fMRI), behavior, and self-report at baseline and week 6. Knowledge gained from this study will help determine the therapeutic potential of targeting the dopamine system to remediate social disconnection as an anxiety and depression intervention.
Read the detailed description
This study seeks to understand how modulating functioning of the neurotransmitter dopamine affects brain circuits, behaviors, and subjective experiences that are believed to underlie an individual's motivation to establish and maintain positive social connections. This knowledge will help advance understanding of brain mechanisms that can be used to better treat social functioning impairments in people experiencing anxiety or depression. The R61 phase project will evaluate the effects of pramipexole (a medication that increases dopamine signaling in the brain) on responses to different types of positive social cues or contexts. The study drug will be given in a 6-week randomized, double-blind, placebo-controlled trial for individuals with clinical levels of anxiety or depression.
Aim 1 will test the hypothesis that pramipexole increases the anticipation of social rewards compared to placebo. Aim 2 will determine which dose of pramipexole (1.0 or 2.5 mg/d) produces a greater effect on social reward anticipation. To achieve these aims, approximately 108 participants (ages 18-50) with clinically elevated anxiety or depression will be randomized across two sites and randomized in equal proportions to one of two doses of pramipexole (1.0 mg/d or 2.5 mg/d) or placebo. They will complete standardized paradigms assessing social reward processing using measures of brain function (fMRI), behavior, and self-report at baseline and week 6. Knowledge gained from this study will help determine the therapeutic potential of targeting the dopamine system to remediate social disconnection.
- Conditions
- Anxiety Disorders, Anxiety, Depression, Social Disconnection
- Being tested
- Pramipexole Pill, Placebo Pill
- Keywords
- Pramipexole, Anxiety, Depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramipexole PillDrug
Also called Mirapex
The study drug, pramipexole, is an FDA-approved medication for the treatment of Parkinson's and restless leg syndrome. Pramipexole (Mirapex) tablets are taken orally, with or without food.
Placebo PillDrug
Placebo will match the study drug in mode of administration, color, size, and taste.
| Study group | Role | What they receive |
|---|---|---|
| Pramipexole 1 mg/d | Active comparator | Each participant will take pramipexole in identical capsular form twice daily for 6 weeks. Receives: Drug: Pramipexole Pill |
| Pramipexole 2.5 mg/d | Active comparator | Each participant will take pramipexole in identical capsular form twice daily for 6 weeks. Receives: Drug: Pramipexole Pill |
| Placebo | Placebo comparator | Each participant will take placebo in identical capsular form twice daily for 6 weeks. Receives: Drug: Placebo Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural activation during social reward anticipation
The primary outcome of interest is blood oxygen level dependent (BOLD) response during anticipation of positive valence social cues vs. baseline in the striatum region of interest (ROI) mask, defined according to a meta-analysis of the social incentive delay task.
Measured: Baseline, week 6
Secondary outcomes (7)
Neural activation during opportunities to disclose to others
Blood oxygen level dependent (BOLD) response in the striatum region of interest (ROI) mask, defined according to a meta-analysis of the social incentive delay task, during share vs. private conditions of the disclosure task.
Measured: Baseline, week 6
Motivation to engage in shared experiences with others
Participants will make choices about whether to watch the same (Shared) vs. a different (Solo) videoclip from their partner. Each option is paired with a small monetary payoff that varies across options and trials. The point of subjective equivalence will be used to quantify the relative payoff difference at which people are indifferent to the two options (0 = maximizing monetary payoff; scores < 0 represent greater value assigned to sharing experiences).
Measured: Baseline, week 6
Positive affect in response to the social affiliation task
The state version of the Positive and Negative Affect Schedule (PANAS) will be used to measure current ("right now") positive affect before (anticipatory) and after (responsiveness) the social affiliation task. Items are answered on a 5 point scale, 1 (Very slightly or not at all) to 5 (Extremely). The positive affect scale ranges from 10-50; higher scores indicate greater levels of positive affect.
Measured: Baseline, week 6
Social approach goals during the social affiliation task
Participants will rate 5 items describing approach-oriented goals focused on obtaining positive outcomes during the interaction. Items are answered on a 7-point scale with anchors of not at all and very much with higher scores indicating greater social approach goals.
Measured: Baseline, week 6
Social approach behavior during the social affiliation task
Observers will rate participant behavior on self-disclosure (the degree of personal information, thoughts, and feelings revealed) and responsiveness (verbal and nonverbal displays reflecting understanding, engagement, and validation). Items are answered on a 7 point scale, 1 (not at all) to 7(very much) with higher scores indicating greater levels of social approach behavior.
Measured: Baseline, week 6
Future approach motivation
The Desire for Future Interaction Scale (DFI) measures the degree to which respondents would be willing to affiliate with their conversation partner again. Items are answered on a 7 point scale, 1 (not at all) to 7 (very much) with higher scores indicating higher levels of future approach motivation.
Measured: Baseline, week 6
Blood plasma pramipexole concentrations
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start13 May 2024
- Primary completionNov 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), New York State Psychiatric Institute
- Responsible party
- Principal investigator, Charles Taylor, University of California, San Diego
- Investigators
- Charles Taylor, PhD, Principal investigator, University of California, San DiegoFranklin Schneier, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269146
- Sponsor's protocol ID
- 806035
- Other IDs
- 1R61MH129380-01
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this study will be submitted to the National Institute of Health Data Archive (NDA).